more evidence pharma barons don't want cures

[donsu]

http://onlinejournal.com/artman/publish/article_2515.shtml


FDA, industry insiders derail approval of new cancer treatments


George W Bush's Food and Drug Administration (FDA), stacked with insiders from the industry that literally carried him to Washington, has stooped to a new low to protect the obscene profits of the multi-billion dollar cancer industry by blocking the approval of a new class of immunotherapies that can extend the lives of dying cancer patients with minimal side effects.

In the May 14 Wall Street Journal, a former medical officer in the FDA Office of Oncology Products, Dr. Mark Thornton, denounced the FDA's decisions, and stated, "May 9, 2007, should be cited in the annals of cancer immunotherapy as Black Wednesday."

"Within an eight-hour period that day," he wrote, "the FDA succeeded in killing not one but two safe, promising therapies designed and developed to act by stimulating a patient's immune system against cancer."

Experts say the new immunotherapies hold promise for many forms of cancer. "FDA's hubris will affect the lives and possibly the life spans of cancer patients from nearly every demographic, from elderly men with prostate cancer to young children with the rarest of bone cancers," according to Dr. Thornton.

With the approval of the new therapies, the profits, along with the horrendous side effects of the only treatments now available, could become a thing of the past. "One day current treatment approaches such as surgery, radiation and chemotherapy, which often kill most but not all of a cancer, could be made obsolete by a potent immune response that eradicates the cancer cells and provides subsequent protection against return and relapse," Dr. Thornton wrote.
-snip-
------------------------

they can't make money off you if you feel better. but if you get sicker, boy!, the money flows into the baron's coffers.

[bobbolink]

1. Are these treatments, or similar ones, available in other countries?

[roguevalley]

69. you can only hope they and their loved ones get the damned

illnesses. then maybe something will happen. or not.

[leftchick]

2. Diabetes is a huge money maker as well

that is why I do not expect a cure anytime soon. :(

[Horse with no Name]

42. That's the exact reason they block stem cell research

It has nothing to do with sanctity of life and everything to do with the sanctity of the dollar.
The pharmaceutical industry would lose trillions of dollars if there were cures for diabetes, cancer, and other high cost disease processes.
I bet if someone were able to follow the money all the way down the rabbit hole, I bet the pharmaceutical industry gives huge premiums to these charlatan churches to stoke the stem cell fury.

[notadmblnd]

3. I think the current cure kills more people than the cancers do.

Of course they don't want people to get well, they might live long enough to retire and collect their entitlements.

[Trillo]

7. But then they should at least be honest and

state that the purpose of modern medicine is primarily to transfer wealth from the ill to the corporatist.

[flashl]

25. I strongly agree. n/t

[Cetacea]

44. That is a fact, actually.

I don't see big Pharma pushing the results of the recent Vitamin D studies either, not to mention hundreds of other promising alternative and cheap treatment plans practiced in other countries.

[havocmom]

56. The current 'cure' sure seems to sell a lot of other drugs to deal with side effects

x(

[CaliforniaPeggy]

4. Of course they don't want cures...

Cures mean you get well, and then you don't need their expensive treatments/medicines/whatever any more...

The dirty bastards...:grr:

[LeftishBrit]

6. Nonsense.

Cures mean that you get well and live long enough to need more cures for other things another day, and eventually geriatric medicines and treatments which are very expensive.

There's enough against pharmaceutical companies anyway, with their shameful failure to make medications affordable for poor people and especially those in developing countries, without assuming that they don't want cures in general.

Sorry to be testy, but I don't like the implication that sometimes exists here of 'cure or nothing' and that long-term treatments for chronic conditions are worthless as they don't *cure*. I would love a cure for my own problem, but meanwhile treatment has revolutionized my life.

[Th1onein]

64. I'm sorry, but you are incorrect.

Genentech even made a statement, years ago, that it wouldn't serve them to find a genetic cure for cystic fibrosis, because they couldn't make any money off of a cure. So, they began concentrating, instead, on a "cure" for allopecia.

[Raine]

53. TOTALLY agree

one reason they are against vitamins and supplements and want them to be by prescription only. They are worried people will become to heathy.

[MonkeyFunk]

5. Well they can't make money

from you if you die from cancer, either.

I know people working in cancer research - to claim they're purposely suppressing cures to make more money is just dumb.

[Trillo]

8. Besides you, who's claiming the workers and scientists

you know are the ones "suppressing cures"?

Several edits later: The issue, at least to me, appears abstractly as a function of hierarchy, and in this particular case, a ruling of the FDA.

[MonkeyFunk]

9. you think

a researcher who discovered a cure for cancer that was kept hidden by "the powers that be" would stay silent about it?

There's a lot to hate about pharmaceutical companies, but they're not suppressing known cures. That's paranoid nutballism.

[Trillo]

11. Not "staying silent", that's why we read of it!

I don't think these immune therapies are "hidden", they appear legally suppressed by the FDA. What oncologist could prudently use them if they're not approved by overseer Big Brother? (and they have to be manufactured which an oncologist wouldn't do anyway: upstream distribution disruption was refined in the war on street drugs like meth in the case of pseudoephedrine, for example)

Yes, I do think it's quite likely that if a treatment either stopped or massively reduced the money flow of expensive treatments, there's certainly a motive to suppress. Just a couple of years ago we heard crying from vaccine manufacturers that there wasn't enough profit to make flu vaccine, and they wanted immunity from lawsuits. Why wouldn't cancer vaccines have the same lack of profit?

Not only is there a motive to suppress, it appears it was suppressed(!), but you're right, we did hear about it. :)

Urol Nurs. 2007 Jun;27(3):256-7.

What happened to the Provenge (Sipuleucel-T) vaccine for hormone refractory prostate cancer?

Moyad MA.

University of Michigan Medical Center, Department of Urology, Ann Arbor, MI, USA.

The preliminary data appeared promising for men with hormone refractory prostate cancer (HRPC). The Food and Drug Administration advisory panel voted 13 to 4 to approve Provenge (sipuleucel-T) and the same panel voted 17 to 0 that it was safe. However, several weeks later the vaccine was not approved. Why did this happen? Why wasn't this novel therapy at least given "provisional" approval status, which simply allows dying patients to receive the medication until the results of the next phase III trial are known? Patients need more options for HRPC because some of the most popular current choices for HRPC were never even FDA approved, but it seems clinicians and patients are desperate for more choices so they are willing to attempt almost any intervention to improve the quality and quantity of life. Regardless, the situation with Provenge is disappointing and should be re-evaluated.

PMID: 17674606

[HiFructosePronSyrup]

12. ...

"The preliminary data appeared promising for men with hormone refractory prostate cancer (HRPC). The Food and Drug Administration advisory panel voted 13 to 4 to approve Provenge (sipuleucel-T) and the same panel voted 17 to 0 that it was safe. However, several weeks later the vaccine was not approved. Why did this happen?"

1. Dendreon, which makes Provenge, is a pharma company. Kinda defeats the argument.

2. The FDA is requiring more data from Dendreon before going through with the recommendations from its advisory board. Usual stuff in the long and difficult process of getting drugs approved.

[Trillo]

13. Non sequitur.

What does the FDA (FYI: Food and Drug Administration) have to do with "pharma companies"? (answer, FDA approves or disapproves pharmaco drugs)

So perhaps not as much a non sequitur, or "defeats the argument" as you would have us believe.

Issues Emerg Health Technol. 2007 Sep;(101):1-4.Links

Sipuleucel-T (Provenge): active cellular immunotherapy for advanced prostate cancer.

McKarney I.

(1) Sipuleucel-T (Provenge) is an active cellular immunotherapy (therapeutic vaccine) that is designed to stimulate the patient's T-cells to recognize and attack prostate cancer cells that express prostatic acid phosphatase (PAP) antigen. (2) Sipuleucel-T demonstrated a survival benefit in men with advanced androgen-independent prostate cancer (AIPC), although this preliminary finding requires confirmation in larger trials. (3) Mild to moderate myalgia, chills, fever, and tremor are the most commonly reported adverse events for patients receiving sipuleucel-T. These events generally resolve quickly. (4) More studies are needed to evaluate sipuleucel-T in the earlier stages of prostate cancer and in combination with conventional therapies.

PMID: 17763575

[HiFructosePronSyrup]

15. Huh?

"So perhaps not as much a non-sequitor, or "defeats the argument" as you would have us believe."

You're arguing that pharma companies don't want to cure cancer because it's not profitable, but here you've got a pharma company trying to get just that through the FDA approval process.

Am I supposed to believe that if the FDA had given it final approval, and it had gone to market, and it turned out it was making people sick that you wouldn't be using it as an example of how bad Pharma companies are? Because I don't.

[Trillo]

18. Have you considered reading lessons?

"You're arguing that pharma companies don't want to cure cancer because it's not profitable, but here you've got a pharma company trying to get just that through the FDA approval process."

That's not what I wrote. Read it again.

[HiFructosePronSyrup]

19. Yeah, I read between the lines.

"But then they should at least be honest and state that the purpose of modern medicine is primarily to transfer wealth from the ill to the corporatist."

[Trillo]

21. And who is the corporatist? n/t

[HiFructosePronSyrup]

22. Jack Ruby?

Shit, as long as we're on loony conspiracy theories, I'll guess Sasquatch.

[Trillo]

27. I'd prefer Random House Webster's unabridged!

cor·po·rat·ism  n.
the principles, doctrine, or system of corporative organization of a political unit, as a city or state.
Also, cor·po·rat·iv·ism .
<1885–90; CORPORATE + -ISM>
—corÆpo·rat·ist, adj.

"Political unit", such as the government, or FDA per chance? Of course the dictionary definition is highly abridged (in spite of 'unabridged' in its title). Corporatism as a word has a much richer history, and "political unit" could even apply to some corporations not thought in the traditional sense to be part of "government", if my reading on the matter is accurate, such as that we learn from Mussolini's corporatist hybrid corporate state.

Wikipedia has an entry for it:
http://en.wikipedia.org/wiki/Corporatism

[HiFructosePronSyrup]

29. So you're comparing the U.S. postal service to Mussolini's fascists?

:rofl:

[Trillo]

30. You brought up the U.S. Postal Service, not me.

I don't see this going further, cause it appears you're here to disrupt for disruption's sake. :hi:

[HiFructosePronSyrup]

31. Hey, it's your goofy argument.

government = political unit
political unit = corporatism
FDA = government
FDA = fascism

since

USPS = government

therefore

USPS = fascism

"I don't see this going further, cause it appears you're here to disrupt for disruption's sake."

I'm trying to have an argument, and I think you resort to accusations of disruption because you're losing the argument so badly.

[Trillo]

71. "USPS = fascism" is your off-topic "therefore".

Telling others that your conclusion is my "goofy" idea is to misrepresent, just like your earlier comments of Sasquatch, they are generally comments apparently meant to demean, belittle, invalidate, and perhaps most importantly, to project false associations into others' minds.

Whether "USPS = fascism" is true or not, or is something in between, it really has nothing to do with the specific topic under discussion, unless perhaps the lawyers to the lawsuit are using USPS's services to communicate with each other, but that doesn't seem your thrust. Perhaps you should start a new GD post with this Conclusion Of Yours to see what others think about it.

You do seem to have a real knack at polarized or "black and white" thinking or assertions, and while others may consider that a weakness, it is clear it is one of your strengths.

Myself, besides finding the duality of such polarization somewhat intriguing in a psychological sense, tend to think that the truth lies at least somewhat in the gray areas either between or encompassing all.

---

If one reads the OP's article, while it may only be one side's argument, it appears that there is big money, big competitors, and big conflicts of interest among a few of the advisory panel members. It appears that part of the article author's story is about how Dendreon, the company that makes Provenge, had a window of opportunity to be the first in the market with an innovative disease-specific vaccine product, and how that window is now closing as a larger, more politically-connected company introduces their competing treatment product, a company that allegedly has financial connections to some on the advisory group that dissented with respect toward approval, and while firmly in the minority, seemed to get their minority vote transformed into another temporal mandate.

The value of being first in any market cannot be overstated, at least that's what I've read and further seen and experienced, that a product first to market tends to dominate even after competitors products are brought to market.

---

I can only speculate as to the reason certain companies would be favored by the FDA in an unfair manner, and other, smaller companies such as Dendreon be required to jump through years of legal hoops resulting in the FDA advisory group's preponderant agreement that their vaccine should be approved and further have unanimous agreement that the vaccine is safe, but still not get final approval in an overall alleged rigged process that has apparently now resulted in a lawsuit that demands more disclosure of backroom dealings, graft, and greed.

Perhaps, and this is the speculation, some companies that are more politically connected have government-backed financing instruments that allow the military and covert agencies to skim money for non-transparent purposes. Some have claimed that is enabled by provisions of the National Security Act of 1947. Wide-scale warrantless wiretapping could surely aid this by keeping small, non-connected firms and individuals under blanket surveillance.

Whatever other unfairnesses may manifest in microaspects of black budget funding with respect to the FDA and favoring of some big companies over smaller companies, the macroaspects of the conception sure do seem to dovetail well with "unexplainable" reasons for continual beyond inflation rate cost increases in healthcare for decades on end, while conventional logic seems to clearly show that advances in scientific and technical and production processes typically result in lower overall costs over time.

The healthcare budget is a large percentage of GDP, medical insurance appears fraught with waste and inefficiencies that swell the portion of costs per capita to twice what it is in other developed countries, so then it seems reasonable to consider the possibility that black budget funding is a component.

If so, that provides a strong motive for covert agencies and operatives to insure their chosen companies are steered to mass profit opportunities, while other companies jump through endless hoops, and that approved treatments are more expensive than necessary.

---

The black budgets appear a major constitutional Hypocrisy under
Article 1, Section 9, Clause 7 of the United States Constitution.

---

That, sir, is my "tinfoil". :tinfoilhat:

[blondie58]

55. being a postal employee, I can tell you that

until recently, the P.O. was not allowed to even make a profit, just to sell enough to cover costs. Recently though, they changed the rules and we are supposed to keep a little extra in reserves. Some of us think that some of the men serving on the Postal Board of Governors, who set the rates, etc. are Repubs, as they don't seem to believe in allowing the service side to function.

[flashl]

26. Lookup Arlin J Brown, he will say "yes". n/t

[HiFructosePronSyrup]

28. Alright, I looked him up.

:rofl:

"Last year, over 700,000 Americans were diagnosed as having cancer and about half a million will die of cancer and another 180,000 or more will have cancer when they die. Less than 3% will fully recover, and each year two-thirds of a million will not recover. About 56 million Americans now living will eventually have cancer and, if the AMA and the Government has its way, over 54 million Americans will die with cancer and at least 120 million will die of heart disease, which, by the way, did not even exist at the turn of the century. In fact cancer itself was rare at that time. If the Federal Government and the death industry allows these 174 million Americans to die of these diseases, it will be guilty of genocide on an unprecedented scale. If we add to this figure another 26 million, which, at the very least, the Government and the disease industry have already murdered, the total will be 200 million. This is at least twice as many human beings as the communists have murdered, in all their Satanic fury.

If there is no inflation whatsoever in the next 20 years and if the incidence of the two leading killer diseases stays the same, then by the year 2001, the death industry will gross five trillion dollars over the coming 20-year period. To show you how much a trillion dollars is, if you had the money of one million millionaires, you would have one trillion dollars.

In addition to all these millions of people dying of cancer and heart disease, there are numerous others dying of diabetes, muscular dystrophy, multiple sclerosis, and a whole raft of other chronic degenerative diseases, most of which did not even exist 100 years ago-and those that did exist were quite rare. But you and I don't have to be part of this carnage.

Animals living on grass and leafy greens are not bothered with these diseases, and humans don't get any of these diseases either if they live on a raw, organic, balanced diet. The people living in Hunza-the "Shangri-La" region of central Asia-never have any degenerative diseases, and their meager, almost 100% vegetarian, diet is two-thirds raw."

Thanks for the laugh.

[Cetacea]

40. Try comparing international studies of alternative treatments

and compare the results to American conventional treatments and then explain why our government continuously goes after doctors trying to apply these alternative treatments here.

[HiFructosePronSyrup]

67. The government goes after them because they're quacks and frauds.

And that's a good thing.

[Telly Savalas]

35. It's pretty simple.

If the FDA approves a drug, then they're bowing to the Corporatists by letting them profit off of a drug that's been foisted on us unsuspecting victims without proper testing.

If the FDA rejects a drug or demands more studies, then it's bowing to the Corporatists by suppressing effective treatments and allowing them to profit off of the ineffective "treatments" they currently market.

Why go to the effort of making reasoned and nuanced arguments about pharmaceutical policy when it's easier to just copy and paste vapid leftist boilerplate?

[gateley]

51. The researcher may have signed over all his/her rights to the pharmaceutical

company and have no legal path to expose the truth.

I would think they're not suppressing known cures EXCEPT if there were no money in the cure for them.

The industry used to dismiss 'natural' treatments, even herbs and vitamins, but now with the growing interest by the populace, all of a sudden they want to step in in the "best interests" of the people.

I think their motivations are suspect. They're in it for the money.

[Cetacea]

41. They are not supressing it themselves.

It's the way the whole system is set up. The system will fail if cheap alternative treatments prevail. And your friends will be working at McDonalds.

[Mike03]

10. I can't speak for anyone but myself

But right now I'm thanking the entire Universe that my father was able to get into a clinical trial for a very successful new drug to treat a rare form of cancer. This is a drug approved in testing for certain individuals that is now be tested as a front-line response to newly diagnosed patients, and it appears he is responding. Also, it is not broad chemo but very targeted so it does not induce the nasty side effects of broad-based chemo.

This is a new treatment that may extend my dad's life, as it as extended the lives of many others who just two years before would have died.

And as for "profit motives," yes it's expensive. $1,000 for one injection. His insurance is covering his therapy, so he is extremely fortunate. The real issue is not pharma conspiracies but AVAILABILITY of life saving drugs (or life-extending drugs) to those who cannot afford them!

[Manifestor_of_Light]

14. Lots of cancer cures available in other countries.

Read up on them and they are often quite simple:

Firstly, Intravenous Vitamin C as sodium ascorbate. I was told by an M.D. that the doctors at M.D. Anderson Hospital, which is the largest cancer hospital in the world, KNOW that intravenous Vitamin C in massive doses (20-50 grams/day for a week or two) will CURE cancer, but they refuse to use it.

Another one: Taking out a person's blood and flooding it with O3 to hyperoxygenate it, and then putting it back in the body.

Thirdly: Giving an 11-year-old child a 5% I.V. solution of baking soda (yes, sodium bicarbonate) to kill a usually-fatal brain tumor, with the result that the child completely recovered from the edge of death, and having your license yanked by the Italian medical boards as a result. Details:
Dr. Tullio Simoncini www.curenaturalicancro.com

Cancer salves. Essiac tea. The Dr. Johanna Budwig diet (cottage cheese and flaxseed oil).

Do some research. Anyone who can cure cancer with a simple regimen and inexpensive ingredients will have their practice ruined, their medical license taken away, and they will be hounded and destroyed. Same thing with technology such as Nikola Tesla's free energy, Dr. Royal Rife and Wilhelm Reich.


Disclaimer: The above is not medical advice. This is not a testimonial. I have no personal experience with these cures. It is merely a statement asking other people to investigate for THEMSELVES.

[HiFructosePronSyrup]

16. LOL

And lets not forget cancer chemopreventiontrails.

[TZ]

23. The biggest proponent of Vitamin C for a cancer "cure"

DIED OF CANCER (Linus Pauling).
These cures are snake oil myths.

[HiFructosePronSyrup]

24. Well sure.

At the age of 93.

[Cetacea]

47. Exactly, And his studies have been vindicated by NIH.

But nobody seems to want to study this cheapest of nutrients.

[HiFructosePronSyrup]

68. Mmm, no they haven't.

Funny thing is, they haven't been properly reproduced.

[Cetacea]

54. Right. TWO time Nobel recipient was snake oil salesman.

Please do some current research on IV Vitamin C and the NIH before you accuse Linus Pauling of being a snake oil salesman. It's a bit insulting.

[Horse with no Name]

46. Sodium Bicarb????

You have got to be kidding? That would result in a metabolic alkalosis that would kill a person. We have even quit giving sodium bicarb in codes UNLESS we have an arterial blood gas IN HAND that shows a deficient quantity because it has proven it KILLS more than it CURES unless there is a specific need for it.
Are you at all familiar with how fragile the human ph is?

[lildreamer316]

65. GREAT post. May I direct your attention, Perragrande,

to this?:
http://www.democraticunderground.com/discuss/duboard.php?az=show_topic&forum=245&topic_id=53088

Post #7 contains the info that you are talking about also.
Just wanted to let you know.... :hi:

[Manifestor_of_Light]

70. Yes I posted in that thread already.

However, I don't know if that NaClO2 (sodium chlorite) in the MMS works or not. I really don't know if any of this stuff works or not. I'm just throwing it out as food for thought, knowing how the pharma industries have bought off politicians.

I remember when the establishment said that anybody who ate a "healthy diet" couldn't possibly have a vitamin deficiency. Then there were people who said to take massive quantities of vitamins of all kinds. Then it settled down.

I think it's a matter of increased biochemical knowledge. The more the investigators learn about metabolism and utilization of chemical compounds, enzymes and so forth, the more they'll learn.

My sister and my father died of cancer, after conventional treatment. My mom had conventional treatment and survived another 23 years. Outcomes vary all over the place.

[judaspriestess]

17. of course they don't want cures, its big money

and population control in their rationale. Its fucked up.

[TZ]

20. Can we say utter HYPOCRISY boys and girls?

The FDA approves Gardasil a vaccine that PREVENTS cancer and you types scream the FDA greenlights everything!
BTW- I am familiar with this class of immunotherapies. They aren't YET proven safe in many scientists eyes.
You do realize that scientists are on the scientific advisory boards of the FDA? Oh and btw, China, which is a lot lightly regulated in terms of new therapies has rushed some of these types of drugs on the market with some really bad results. Perhaps you would prefer to have people die from rushed products? (Vioxx comes to mind).
As for no cures-HA! Here are some of the products being tested in clinical trials at the moment---Vaccines to prevent/treat ulcers/stomach cancers, various HIV vaccines, vaccines that have been shown to attack and reduce cancerous BRAIN TUMORS, and various monoclonal antibodies that are designed to attack and KILL cancer cells along with other more effective HPV vaccines. Yeah sure, prevention and treatment of cancer is suppressing cures.....:sarcasm:

[Trillo]

32. No, the people who were screaming about Gardasil were objecting

in reference to the Governor of Texas signing an executive order (IIRC, didn't look it up) to FORCE all girls to use take it. I don't recall many people objecting to its voluntary (by choice) use.

To keep this on point, one of the later academics (Provenge -- I posted an abstract upthread) said approval needed (paraphrasing) further study for earlier states of the disease AND combined with conventional therapies.

In another abstract the FDA's advisory panel, while not unanimous, was at least 2/3 for approval, and all considered it "safe".

So it seems the allusion to Gardasil is another non sequitur which has little to nothing to do with this Provenge vaccine, unless once it's approved it becomes a forced treatment protocol.

[TZ]

33. Do you understand that approval of a NEW CLASS of drugs

can take UP TO 2-3 YEARS? I read about Provenge. This is not a clear cut case-YET. I believe they want more data, which to me is never a bad thing. This is also one biotech vs. another biotech so its not about not suppressing a profit- it has to do with a rivalry between particular companies where one believes the drug is dangerous and the other doesn't. Its about a BRAND NEW technology-also some desperate patients have taken Provenge with some very bad and alarming trends, including threatening (and in at least one case assaulting) some doctors on the panels who were skeptical about the safety issues The FDA also tends to get conservative on approving new drugs like Provenge after seeing what happened with Avandia and Vioxx
FYI- I had people claiming that Gardasil was NOT tested thoroughly even though it had been through 10+ years of clinical trials. I had people screaming about being guinea pigs with Gardasil that Merck was putting profits over safety which was far far far from the truth.
As much as it aggravates me to see the FDA drag its feet sometimes (in a PR effort occasionally) I would rather see new drugs get thoroughly tested. After all, companies are ALWAYS looking for participants in clinical trials AND because they are experimental.. that includes FREE medical treatment, so in some ways staying in clinical trials makes a drug MORE available for those who REALLY need it.

[Trillo]

36. Do you have a link? ("bad and alarming trends")

This thread really isn't about Gardasil, but I do remember the Governor of one of the Dakotas saying something about it being voluntary in their state, this was a short time after the Republican Governor of Texas incident, and the post dropped like a rock.

You wrote: "This is also one biotech vs. another biotech so its not about not suppressing a profit- it has to do with a rivalry between particular companies where one believes the drug is dangerous and the other doesn't."

Hmm, seems to me that competition of one company against another IS about profit, they can mask their profit concerns anyway they like, including objecting about safety. More than 2/3 on the advisory panel voted for approval at the FDA, but less than 1/3 can hold it up, even when that same 1/3 and the other 2/3 agrees it's "safe"?

I'm just skeptical of your claims of danger, that's why I asked for a more authoritative source regarding the "bad and alarming trends."

The concern I have, and I think it's expressed well in the OP's linked article, is that this seems less about science and more about profit and competition (which can and does translate to politics when big biz is involved), and it seems like the FDA should be more about science and less about politics, but under BushCo, it's not surprising that it isn't.

"Do you understand that approval of a NEW CLASS of drugs can take UP TO 2-3 YEARS?"

Here's an excerpt that suggests this has been studied for a few more years than 2-3.

J Clin Oncol. 2000 Dec 1;18(23):3894-903.

Immunotherapy of hormone-refractory prostate cancer with antigen-loaded dendritic cells.

Small EJ, Fratesi P, Reese DM, Strang G, Laus R, Peshwa MV, Valone FH.

Department of Medicine and Urology, University of California San Francisco Comprehensive Cancer Center, University of California, San Francisco, CA 94115, USA. >snip<

PURPOSE: Provenge (Dendreon Corp, Seattle, WA) is an immunotherapy product consisting of autologous dendritic cells loaded ex vivo with a recombinant fusion protein consisting of prostatic acid phosphatase (PAP) linked to granulocyte-macrophage colony-stimulating factor. Sequential phase I and phase II trials were performed to determine the safety and efficacy of Provenge and to assess its capacity to break immune tolerance to the normal tissue antigen PAP. PATIENTS AND METHODS: All patients had hormone-refractory prostate cancer. Dendritic-cell precursors were harvested by leukapheresis in weeks 0, 4, 8, and 24, loaded ex vivo with antigen for 2 days, and then infused intravenously over 30 minutes. Phase I patients received increasing doses of Provenge, and phase II patients received all the Provenge that could be prepared from a leukapheresis product. RESULTS: Patients tolerated treatment well. Fever, the most common adverse event, occurred after 15 infusions (14.7%). All patients developed immune responses to the recombinant fusion protein used to prepare Provenge, and 38% developed immune responses to PAP. Three patients had a more than 50% decline in prostate-specific antigen (PSA) level, and another three patients had 25% to 49% decreases in PSA. The time to disease progression correlated with development of an immune response to PAP and with the dose of dendritic cells received. CONCLUSION: Provenge is a novel immunotherapy agent that is safe and breaks tolerance to the tissue antigen PAP. Preliminary evidence for clinical efficacy warrants further exploration.

PMID: 11099318

[HiFructosePronSyrup]

34. Mmm, no they weren't.

"in reference to the Governor of Texas signing an executive order (IIRC, didn't look it up) to FORCE all girls to use take it. "

The executive order had an opt-out policy. So nobody was forced into nothing.

"In another abstract the FDA's advisory panel, while not unanimous, was at least 2/3 for approval, and all considered it "safe"."

Either way, the advisory panel is not the final step for approval. So I don't see what your point is.

"So it seems the allusion to Gardasil is another non sequitur which has little to nothing to do with this Provenge vaccine, unless once it's approved it becomes a forced treatment protocol."

It's a cancer preventative from a big Pharma company, with approval from the FDA. Which totally debunks your conspiracy theories.

[Cetacea]

52. Explain the resistance for using IV Ascorbate

It's cheap. Very cheap. It's been proven to improve the quality of life and
extend life for the cancer patient. Read the recent findings of the NIH on C and explain why this is not a treatment RIGHT NOW. (especially for stage 4 patients).

[Trillo]

37. Kicking for one more rec! n/t

[focusfan]

38. That last line is the very thing I have been preaching for years

Doctors are just like crooked auto mechanics selling you 8 injectors while only one is bad or rebuilding your transmission when you only have a blown fuse.They can`t make a proffit if they are honest or at the very least cure you.

[Horse with no Name]

43. Doctors have nothing to do with it

it's the moneychangers.

[superkia]

39. This is why I disagree with the notion that non profit health care...

will hurt the process of finding more cures and new medicines. With the profit coming from sick people, what drug company wants to cure anything? The system the way it is now only keeps cures hidden and away so they can help us live with things instead of curing them, its more profitable that way. I wish more of the so called front runners would adopt Kucinichs non profit health care plan instead of the current ones that profit by denying people and only giving partial payments. I guess to be a front runner, you must stand for the corporations and not the people like you are elected to do?

[Perseid]

45. my brother just died from cancer

I take one maintenance type pill daily to control blood pressure. The docs tried to get me to take three, and another one for cholesterol.

I lost weight. A lot of weight, and now have borderline low blood pressure, and my cholesterol is fine.

Every drug they tried to throw at me was a lifetime "maintenance" drug. Nothing ever cures anything anymore, and half the drugs are for nonexistent illnesses.

[cyberpj]

48. Read the entire article - you won't believe the conflicts of interest and money involved.

I'm truly beginning to feel lost and hopeless in fighting anything anymore.
Starting to feel too overwhelmed to try to help any cause at all.
Sigh.........................................................................

[Mike03]

58. Me too

But I have to be optimistic for my father. He seems to have doctors who really care about him, who shed tears, who hate the illness he faces.

Otherwise, I don't have anything really to hold onto any more.

[Catherine Vincent]

49. This is very depressing to read.

It always comes down to money and how much they can make. No wonder they came out with the phrase "money is the root of all evil". Sometimes I believe that.

[Cha]

50. Rec'd~ We all know

at least one person who has cancer if not more..if they got cured and there wasn't any future cancer where would that leave the drug companies?

Billions outta their Trillions less a year?

I hope with a Dem prez in we can get rid of these heinous pod people bent on destroying everything in their site that doesn't bring them billions of $$$$$$$$$$$$$$$$ a year.

[pinto]

57. Another point of view: ' Not FDA To Blame' (Dr. Charles Myers, UVA Cancer Center)

Provenge
sipuleucel-T

Treatment for Prostate Cancer
D.C. Denies Prostate Cancer Vaccine, Provenge: Dendreon (WA) Not FDA To Blame

CHARLOTTESVILLE, Va., July 30, 2007 /PRNewswire/ -- Many in the prostate cancer community are still outraged over the FDA's decision to deny approval for the immunotherapy drug Provenge. Some have even gone as far as to make threats against Howard I. Scher of Memorial Sloan-Kettering Cancer Center (NY) and Maha Hussain of University of Michigan, two physicians who influenced this decision.

However, Dr. Charles "Snuffy" Myers, leading PC oncologist and VA prostate cancer survivor, remains staunch in his objections to the trials Dendreon presented to the FDA despite the benefits the drug might bring to his patients and himself. Myers has written extensively on this subject in his Prostate Forum newsletters 10 #01 and 10 #02, available at http://www.prostateforum.com.

"Dendreon made major and obvious mistakes in developing Provenge. The FDA is not some sort of bad guy -- at least in this case and yet Dendreon's stock continues to rise," Myers' says. "The primary end point of a clinical trial seeking FDA approval should be either survival or improved quality of life, but Dendreon still chose to muddy the waters by changing endpoints midway through the clinical trial, forcing the FDA's hand with their poor design."

"This is actually the second time that we've had a useful drug fail in development. The other was Atrasentan (a.k.a. Xinlay)," Myers adds. "Again, it failed not because of the FDA but because of drug company incompetence. While the FDA is far from perfect, people need to understand who to blame in this case."

"I can understand the anger," Myers says, "but is it really unreasonable to ask for proof that a drug is safe and either improves survival or quality of life? I think that Provenge is an active agent with a definite, but limited, benefit, so I feel a personal loss now that it is not going to be available. But killing the messenger doesn't change the message; it just obscures the real problem -- and solving problems is what modern medicine should really be about."

Former director of the UVA Cancer Center, Dr. Charles "Snuffy" Myers is the author of the acclaimed Beating Prostate Cancer: Hormonal Therapy & Diet and runs the American Institute for Diseases of the Prostate to treat patients with the same tools that saved his own life. For more information or to read Dr. Myers' opinions on Provenge visit http://www.prostateforum.com.

Bio of Dr. Myers: http://www.prostateforum.com/about.htm
--------------------------------------------------
http://www.drugs.com/nda/provenge_070730.html

[Trillo]

60. Thanks for an alternate point of view.

Two red flags that I see.

• The source, PRNewswire: that probably means it is a "paid" news item.


• The doctor's middle nickname, Charles "Snuffy" Myers.

Why would any reputable oncologist pay to cast his criticism of a company's study, regarding a company he's not associated with, far and wide? Couldn't he get some reporter time? Even better, some science or medical journal time?

If any study was poorly designed, then surely someone would be willing to reprint those concerns without "Snuffy" needing to pay for that distribution out of his own wallet. Or did someone else pay for "Snuffy's" criticisms to be distributed?

[pinto]

62. Your welcome. I see your first point, your second seems besides the point. His bio

(cited in the post) seems reputable:

Dr. Myers was graduated near the top of his class from the University of Pennsylvania School of Medicine in 1969. While at Penn, he worked in the laboratory of Peter Nowell, the scientist who discovered the genetic basis (the Philadelphia Chromosome) for one of the common forms of leukemia. He also completed his internship and part of a residency in internal medicine at the Hospital of the University of Pennsylvania between 1969 and 1971.

In 1971 he began training in medical oncology at the National Cancer Institute with Vincent DeVita. This was an exciting time to join NCI because DeVita had just demonstrated that widespread metastatic Hodgkin's disease could be cured by aggressive use of chemotherapy. During the three years Myers trained there, DaVita demonstrated that chemotherapy cures other types of lymphoma. Additionally, modern chemotherapy was developed for ovarian and breast cancer at NIH during that time. At the end of his fellowship, the first board certification examinations in Medical Oncology were given, signaling the birth of this specialty.

and - as with all medical researchers - connected tangentially to funding.

Conflating intent or ethics with funding seems a broad brush approach to any discussion about treatment - and outcomes. And outcomes seem to be Dr. Myers point.

(aside) It's worth noting he has had prostate cancer and has a patient's point of view, as well.

[pinto]

63. and while Ms. Pringle may be a fine investigative journalist - I don't see technical expertise to

critique technical drug trial data, objectivity to assess benefit/risk concerns, or any attempt to look at other points of view.

I don't have the technical expertise either. So, I look for the training behind the opinion.

I appreciate her input, though. It's worth note.

In the final analysis, we all make our own decisions on treatment options based on all the available info.

[Mike03]

59. Some people can be kind of crass, sarcastic and flippant about

this topic. But, man, if someone you love is in the grips of the medical system and their life depends on honest medicine and credible studies, then there is nothing to joke about, nothing to be sarcastic or judgmental about. You just have to believe that your loved one's doctors actually give a shit.

[bonito]

61. Great post,

As soon as folks realize that even medicine is a money game, don't get me wrong there's a whole lot going on in medicine for the good, but there IS the greed factor, so I advise (by way of experience) check out what is called alternative medicine and go there as your life depends on it. Peace

[nashville_brook]

66. ...